BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3923029 · Received July 9, 2014

    Report

    Report Number
    1031452-2014-03300
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORANGE INDICATOR LIGHT ON AN IRC5LXO2 CONCENTRATOR IS FLASHING. THE O2 SENSOR IS NOT READING THE O2 LEVEL CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400505 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other